NCT01285635

A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck

A Phase II of AT-101 in Combination With Docetaxel in Patients With Recurrent, Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the effects of an investigational drug called AT-101 in combination with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop growing? The researchers will also learn about the safety of the combination of AT-101 and Docetaxel. For instance, are there any side effects? If so, what kind of side effects does the combination cause? How severe are the side effects, and how often do they occur?

Conditions

• Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Interventions

Type	Name	Description
DRUG	AT-101	Pulse Dose: AT-101 dose of 40 mg b.i.d. on days 1-3 Metronomic Dose: AT-101, 20 mg daily, days 1-14
DRUG	Docetaxel	Docetaxel 75 mg/m2 on Cycle Day 1

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-12-01
• Completion: 2015-09-01
• First posted: 2011-01-28
• Last updated: 2016-03-31
• Results posted: 2015-07-23

Locations

2 sites across 1 country: United States